Prosthetic valve for a blood vein and an associated method of implantation of the valve

Abstract

A prosthetic valve and an associated method of implanting the valve within a blood vein utilize a valve support ring and a pair of leaflet members pivotally connected to the ring. The valve is positionable within a radial plane of the blood vessel for permitting substantially unidirectional flow through the blood vein. The support ring is not required to be sutured within a blood vein and instead includes an outer surface defining a radially outwardly-directed annular groove, so that the valve can be secured within the blood vein by means of a cord tied around of the blood vein and in a tightened condition within the annular groove. The support ring is held in such fixed position along the length of the blood vein because the blood vein is held between the support ring outer surface and the cord. Furthermore, the support ring outer surface is contoured in such a manner so that when the valve is operatively secured within a blood vein, the inner wall of the blood vein lies in substantial conformity to the shape of the ring outer surface.

I claim: 
     
       1. A method of implanting a prosthetic valve within a blood vessel comprising the steps of: providing a prosthetic valve including (a) a support ring positionable within said blood vessel and having an outer surface which includes an outwardly facing annular groove, and   (b) leaflet means connected to said support ring in a manner permitting substantially unidirectional flow through said ring;     forming an opening in the blood vessel at a location therealong spaced from the location at which said valve is desired to be implanted;   inserting said prosthetic valve through the formed opening to such desired location at which said valve is to be implanted and orienting said valve so that said support ring thereof is generally in a radial plane of said blood vessel;   providing cord means;   tightening the cord means about the outer wall of the blood vessel such that the proximate portion of the blood vessel is caused to assume the contour of said groove: and   holding such tigntened cord means so that said support ring is held in such desired position.   
     
     
       2. The method of claim 1 wherein the step of forming an opening includes the further step of cutting the blood vessel for a substantial distance around, but not all of, the circumference of said blood vessel. 
     
     
       3. The method of claim 2 wherein the step of cutting includes the further step of incising the blood vessel so that the incision formed therein is oriented generally within a radial plane of said blood vesel. 
     
     
       4. The method of claim 1 wherein the step of orienting said support ring in the radial plane of the blood vessel includes the further step of arranging the valve within the blood vessel so that the direction in which flow is permitted through the valve corresponds to the direction of flow through the blood vessel. 
     
     
       5. The method as defined in claim 1 wherein the step of holding is followed by the additional step of: closing the formed opening in the blood vessel.   
     
     
       6. The method of claim 5 wherein said step of closing the formed opening includes the steps of: positioning opposite sides of the opening adjacent one another: and   stitching such opposite together.   
     
     
       7. A prosthetic valve adapted to be inserted into a blood vessel and held in a desired position therein without suturing the same, comprising: an annular thin-walled support ring having a substantially-constant wall thickness and having an undulating longitudinal cross-section extending between first and second annular end faces, said ring having an outer surface which includes an annular first convex surface joining said first end face, an outwardly-facing annular groove, and a second annular convex surface joining said second end face, said ring having an inner surface extending between said end faces, said inner surface having an inwardly-extending bulge to accommodate the contour of said groove; and   leaflet means mounted on said support ring for movement toward and away from said bulge to permit only unidirectional flow through said support ring;   whereby said valve may be inserted into said blood vessel such that the longitudinal axis of said support ring is substantially coincident with the axis of elongation of said blood vessel, and held in such position by means of a tightened cord holding a proximate portion of said blood vessel in said groove.   
     
     
       8. A prosthetic valve as set forth in claim 7 wherein the outer surface of said support ring is generally sinusoidal in a longitudinal direction between said end faces. 
     
     
       9. A prosthetic valve as set forth in claim 8 wherein the axial length of said support ring outer surface occupies a period of about 540°. 
     
     
       10. A prosthetic valve as set forth in claim 7 wherein said support ring outer surface is roughened. 
     
     
       11. A prosthetic valve as set forth in claim 7 wherein said leaflet means includes at least one leaf pivotally mounted on said support ring for movement toward and away from said bulge. 
     
     
       12. A prosthetic valve as set forth in claim 11 wherein said leaflet means includes two leaves pivotally mounted on said support ring for movement toward and away from said bulge. 
     
     
       13. A prosthetic valve as set forth in claim 11 wherein each leaf is arranged to selectively abut said bulge. 
     
     
       14. A prosthetic valve as set forth in claim 11, and further comprising: a shaft extending substantially diametrically across said ring with its end faces engaging said bulge.   
     
     
       15. A prosthetic valve as set forth in claim 14 wherein said shaft is press-fit into engagement with said support ring. 
     
     
       16. A prosthetic valve as set forth in claim 14 wherein each leaf has a barrel portion encircling said shaft. 
     
     
       17. A prosthetic valve as set forth in claim 7 wherein said valve means is positioned within a blood vessel, and further comprising: cord means adapted to be tightened about said blood vessel and valve for causing a proximate portion of said blood to assume the contour of said support ring outer surface.